Mar

2000

Abbott Labs – Glucose Monitor DMS Class ll

PRODUCT

a) Precision Link Blood Glucose Data Management System Software Version 2.0 and 2.1; b) Precision Link Plus Data Management Software Version 1.0. The program extracts test results from glucose monitors and converts these results into charts, graphs, and reports. It provides information to monitor diet, exercise, and
medication. Recall #Z-913/914-0.

REASON

Glucose values greater than 600mg/dl are downloaded incorrectly.

CODE

a) Software Versions 2.0 and 2.1; b) Software Version 1.0.

MANUFACTURER

Abbott Laboratories, Inc., Bedford, Massachusetts.

RECALLED BY

Medisense, Inc., Bedford, Massachusetts, by letter on March 13, 2000.
Firm-initiated field correction ongoing.

DISTRIBUTION

Nationwide.

QUANTITY

a) 16,179 units; b) 1,113 units were distributed.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Abbott Labs – Glucose Monitor DMS Class ll

Amy Sellers

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